This phase 2 trial will investigate the effect of low-dose quadruple-combination therapy (LDQT) in patients with hypertension.
The main outcome will be the change in systolic blood pressure (SBP; blood pressure when the heart contracts). This study is recruiting in Illinois, US.
The details
Hypertension or high blood pressure (BP) is a common and serious condition. Managing BP levels is important to prevent organ damage and cardiac events e.g. heart attack. Managing BP can sometimes require multiple medications. There are many ways to target BP. Combining treatment can be very effective. Some products have been developed to combine multiple drugs. The idea is that combining drugs will improve adherence to medication. It may also reduce the dose of drug required to manage BP. One of these is an ultra-low-dose quadruple combination therapy (LDQT). It combines 4 drugs at low doses. These included candesartan (Atacand), amlodipine (Norvasc), indapamide (Lozol), andbisoprolol (Zebeta).
This trial will investigate the effect of LDQT in patients with hypertension. The main outcome will be the change in SBP.
Who are they looking for?
This trial will recruit 365 patients with hypertension. Only patients treated with a maximum of one BP drug will be eligible. Participants must provide 24 months of BP history from their doctor.
Patients that cannot take one of the LDQT drugs cannot take part in the trial. Patients with a previous history of coronary artery disease or heart events (such as a heart attack or stroke) are excluded from the trial. Protein in urine is another exclusion criteria. Hypertension caused by kidney dysfunction does not qualify for this trial. Pregnant and breastfeeding women are also excluded from the trial.
How will it work
Patients will be randomly assigned to LDQT or a comparator drug. The comparator is candestartan (8 mg). Both treatments will be taken once daily for 12 weeks. 24-hour blood pressure monitoring will be performed. Systolic BP (SBP) and diastolic BP (DBP) will be measured. SBP is the pressure in the heart when it pumps blood out of it.
The main outcome will be the change in SBP at 12 weeks.
